ISO 9001: 2015

GENERAL BRIEFING

Introduction

• There is a need to upgrade Quality Management System to new edition of

the standard and seek certification to it.

• A three-year transition period from the date of publication (September 2015)

to move to the 2015 version.

• This mean that, after the end of September 2018, a certificate to ISO

9001:2008 will no longer be valid.

CONTENTS

• Standard Overview

(Comparison in between ISO 9001:2008 & ISO 9001:2015)

• ISO 9001 clauses changes

• High Level Structure (HLS) of ISO 9001- 2015 (PDCA)

Standard Overview

Main Changes of ISO 9001:2015

• Use of the High Level Structure

• Improved applicability for services

• Fewer prescribed requirements

• Increased emphasis on

organizational context

• Boundaries of the QMS must be

defined

• Risk-based thinking throughout the

standard supersedes a single clause

on preventive action

• The term ‘documented

information’ replaces ‘documents

and records’

HIGH LEVEL

STRUCTURE (HLS)

Reason for changes

• Decrease the emphasis on Documentation

• Increase the emphasis on Achieving Value for the Organization & its

customers

• Increase emphasis on Risk Management to achieve objectives

Mandatory documents and records required by

ISO 9001:2015

• Scope of the QMS (clause 4.3)

• Quality policy (clause 5.2)

• Quality objectives (clause 6.2)

• Criteria for evaluation and selection of suppliers (clause 8.4.1)

NOTES: Here are the documents you need to produce if you want to be compliant with ISO 9001:2015.

(Please note that some of the documents will not be mandatory if the company does not perform

relevant processes.)

Mandatory documents and records required by

ISO 9001:2015

And, here are the mandatory records (note that records marked with * are only mandatory in cases when the relevant clause is not excluded):

• Monitoring and measuring equipment calibration records* (clause 7.1.5.1)

• Records of training, skills, experience and qualifications (clause 7.2)

• Product/service requirements review records (clause 8.2.3.2)

• Record about design and development outputs review* (clause 8.3.2)

• Records about design and development inputs* (clause 8.3.3)

• Records of design and development controls* (clause 8.3.4)

Mandatory documents and records required by

ISO 9001:2015

• Records of design and development outputs *(clause 8.3.5)

• Design and development changes records* (clause 8.3.6)

• Characteristics of product to be produced and service to be provided (clause 8.5.1)

• Records about customer property (clause 8.5.3)

• Production/service provision change control records (clause 8.5.6)

• Record of conformity of product/service with acceptance criteria (clause 8.6)

Mandatory documents and records required by

ISO 9001:2015

• Record of nonconforming outputs (clause 8.7.2)

• Monitoring and measurement results (clause 9.1.1)

• Internal audit program (clause 9.2)

• Results of internal audits (clause 9.2)

• Results of the management review (clause 9.3)

• Results of corrective actions (clause 10.1)

Non-mandatory documents

There are numerous non-mandatory documents that can be used for ISO 9001 implementation. However, I find these non-mandatory documents to be most commonly used:

• Procedure for determining context of the organization and interested parties (clauses 4.1 and 4.2)

• Procedure for addressing risks and opportunities (clause 6.1)

• Procedure for competence, training and awareness (clauses 7.1.2, 7.2 and 7.3)

• Procedure for equipment maintenance and measuring equipment (clause 7.1.5)

• Procedure for document and record control (clause 7.5)

• Sales procedure (clause 8.2)

Non-mandatory documents

• Procedure for design and development (clause 8.3)

• Procedure for production and service provision (clause 8.5)

• Warehousing procedure (clause 8.5.4)

• Procedure for management of nonconformities and corrective actions (clauses 8.7 and 10.2)

• Procedure for monitoring customer satisfaction (clause 9.1.2)

• Procedure for internal audit (clause 9.2)

• Procedure for management review (clause 9.3)